Dietary Assessment and Mycotoxin Exposure in Celiac Disease

August 26, 2015 updated by: Leda Roncoroni, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Dietary Assessment and Mycotoxin Exposure in Celiac Subjects

Celiac disease (CD) is the most common autoimmune enteropathy in Western Countries. Gluten free diet is the only available therapy but few is known about its nutrient content and mycotoxin exposure.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Celiac disease (CD) is the most common autoimmune enteropathy in Western Countries, occurring in genetically susceptible individuals, elicited by the gluten ingestion. By definition the disease responds to gluten withdrawal, so currently gluten free (GFD) diet is the therapy for celiac patients. It is known that gluten rich products are important source of nutrients on the other hands it is not clear if gluten exclusion from the diet could have a negative effect on the nutritional status of CD patients.

Another concern related to the GFD could be the high exposure to mycotoxins due to the high concentration of maize in GF products.

AIM The aim of this study is to estimate the nutrient intake and the dietary exposure of all mycotoxin types in a group of treated celiac patients vs. non-celiac subjects.

METHODS We will enroll celiac patients and healthy controls. Exclusion criteria for celiac patients will be: 1) diagnosis of CD less than two years 2) age under 18 or over 70 3) associated metabolic or chronic disease 4) pregnancy or lactation 5) being vegetarian or vegan. Exclusion criteria for the healthy subjects will be the same with the exception of the diagnosis of CD.

Total food and beverage consumption will be assessed by means of a 7 days long questionnaire. All participants will be trained by a nutritionist to record all food consumed and the completed forms will be returned and reviewed during a face-to-face interview at which portions size were quantified in standard units. Participants will be asked to weigh all foods and drinks consumed and to provide a detailed description of each food, including methods of preparation and recipes, whenever possible. In case of Gluten Free Foods, patients will be asked to precisely note the name of the manufacturer or to provide the food label.

The nutrient intake was calculated using a software application linked to the food database of the European Institute of Oncology integrated with the nutrient composition of 60 commercial GF foods. The computer output will consist in the evaluation of the mean daily intake of macro nutrients for each subject, in terms of carbohydrates, protein and lipid. Food items consumed will be also collapsed into food categories; pasta, bread, potatoes, flours, different cereals, fruit, vegetables, milk, cheese, eggs, fish, oils and fats, biscuits, sweet snacks, breakfast cereals, candies, chocolate, soft drinks, juices, coffees, teas, alcoholic beverages. For each subject, the mean daily intake of each food category will be calculated.

The 24-h urines were collected at the end of the registration period and analyzed for mycotoxins.

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
      • Milano, Italy, 20122
        • Recruiting
        • Celiac Disease Center, Fondazione IRCCS Cà Granda

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 68 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

adult subjects with or without celiac disease

Description

Inclusion Criteria:

  • celiac disease diagnosis
  • GFD for at least 2 years

Exclusion Criteria:

  • follow a vegetarian diet
  • being affected by important systemic or psychiatric disorders
  • incapacity to fill the questionnaires

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Celiac
patients with celiac disease filling the questionnaire and undergoing urinary test
Other: food questionnaire
Other: Urinary mycotoxin test
healthy controls
healthy patients filling the questionnaire and undergoing urinary test
Other: food questionnaire
Other: Urinary mycotoxin test

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mycotoxins
Time Frame: mycotoxins will be measured at the end of a 7 day period and the completion of the dietary questionnaire
Urinary measure of mycotoxins
mycotoxins will be measured at the end of a 7 day period and the completion of the dietary questionnaire

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
dietary questionnaire
Time Frame: 7 days
during a 7 days lonf period the patients will be invited to fill a complete dietary questionnaire on the basis of the questionnaire results the nutritional status will be evaluated At the end of these 7 days the patients will collect the 24h urine for mycotoxin dosage
7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Collaborators

University of Parma

Investigators

  • Study Chair: Luca Elli, MD, Celiac Disease Center, Fondazione IRCCS Cà Granda
  • Study Chair: Nicoletta Pellegrini, University of Parma
  • Study Chair: Dario Conte, MD, Celiac Disease Center, Fondazione IRCCS Cà Granda

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2013

Primary Completion (Anticipated)

December 1, 2015

Study Completion (Anticipated)

July 1, 2016

Study Registration Dates

First Submitted

October 23, 2013

First Submitted That Met QC Criteria

October 28, 2013

First Posted (Estimate)

November 3, 2013

Study Record Updates

Last Update Posted (Estimate)

August 27, 2015

Last Update Submitted That Met QC Criteria

August 26, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 852/12
  • GFD/2012 (Other Identifier: Fondazione IRCCS Cà Granda administration)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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